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NCT Number: NCT04578171

Residual Exacerbations With Mepolizumab

This will be a two-year prospective study to characterize the nature of the remaining asthma exacerbations in patients treated with mepolizumab. Participants will be assessed every six months from pre- until two years of treatment in addition to whenever they experience an exacerbation of asthma during the study period. During these visits, various clinical, physiological and inflammatory outcomes will be assessed.

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Key information

Conditions

Asthma Bronchial Diseases Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Inflammation Lung Diseases Lung Diseases, Obstructive Pathologic Processes Pathological Conditions, Signs and Symptoms Respiratory Hypersensitivity Respiratory Tract Diseases

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Institut universitaire de cardiologie et de pneumologie de Québec

Québec, Quebec, G6K 1L8, Canada

Location status: Recruiting

About this study

Before initiation of mepolizumab, a recording of patient's demographics, clinical, physiological and inflammatory features will be recorded. All subjects will be reassessed for the above measures at 6, 12, 18 and 24 months.

In addition to the above visits, patients will be assessed every time they experience either moderate or severe exacerbation of asthma over the treatment period.

Based on the percentage of sputum eosinophils and neutrophils, the type of inflammatory exacerbation will be determined

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • With a proven diagnosis of severe asthma as defined by the Canadian Thoracic Society
  • Eligible for mepolizumab treatment
  • Able and willing to sign the informed consent form

Exclusion criteria

  • Any respiratory disease apart from asthma
  • Confounding comorbidities sur as eosinophilic granulomatosis with polyangiitis (EGPA) or hypereosinophilic syndrome

Treatment and study plan

Mepolizumab

Drug

100 mg subcutaneous injections every four weeks

Other names: nucala

Primary outcomes

  1. Proportion of eosinophilic vs non-eosinophilic remaining exacerbation during the treatment period

    Time frame: Between baseline and month 24

    Eosinophilic exacerbation defined as >=3% sputum eosinophils. Ratio of eosinophilic vs non eosinophilic asthma exacerbation

Secondary outcomes

  1. Change from baseline in asthma control on the Asthma Control Questionnaire (ACQ-5) at 24 months

    Time frame: Baseline and month 24

    The ACQ-5 is a validated, self-reported questionnaire assessing asthma control over the last week. Possible scores range from 0 (complete control) to 5 (no control). Change = (Month 24 score - baseline score)

  2. Change from baseline in post-bronchodilator forced expiratory volume in one second (FEV1) at 24 months

    Time frame: Baseline and month 24

    Value of FEV1 measured after inhalation of 400ug of salbutamol. Recorded in Li. (Month 24 FEV1 value - baseline FEV1 value)

  3. Change from baseline in post-bronchodilator FEV1/forced vital capacity (FVC) ratio at 24 months

    Time frame: Baseline and month 24

    Value of FEV1/FVC measured after inhalation of 400 ug of salbutamol. (Month 24 value - baseline value)

  4. Change from baseline in fraction of exhaled nitric oxide (FeNO) levels at 24 months

    Time frame: Baseline and month 24

    Recorded in ppb using the mean of two reproducible measurements. (Month 24 value - baseline value)

  5. Change from baseline in percentage of sputum eosinophils at 24 months

    Time frame: Baseline and month 24

    Determined from induced sputum analysis. (Month 24 sputum eosinophil percentages - baseline sputum eosinophil percentages)

  6. Change from baseline in percentage of sputum neutrophils

    Time frame: Baseline and month 24

    Determined from induced sputum analysis. (Month 24 sputum neutrophil percentages - baseline sputum neutrophil percentages).

Interested in participating?

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Interested in participating?

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Sponsors and collaborators

Lead sponsor

Laval University

Other

Collaborators

  • GlaxoSmithKline

Registry information

Official study title

Type and Mechanisms of Residual Asthma Exacerbations in Patients Treated With Mepolizumab

Important dates

Study start
2021
Primary completion
2027
Study completion
2028
First posted
Oct 8, 2020
Registry last updated
Feb 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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